Development

Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board, explores the complicated world of phase 3 trials for biosimilars to answer the question of whether they are truly needed for establishing biosimilar safety and efficacy.

The FDA granted a new indication for rheumatoid arthritis for Riabni, a rituximab biosimilar, and Organon and Shanghai Henlius Biotech entered into a licensing agreement for 2 oncology biosimilar candidates.

Data showing the clinical outcomes of Samsung Bioepis’ biosimilar referencing Humira (adalimumab) were shared at the European Congress of Rheumatology’s annual meeting, EULAR 2022.

With multiple adalimumab biosimilars poised to enter the market and more biosimilars in more disease states seeking interchangeability, the US market is entering a new phase of biosimilar use.

Alvotech released new data demonstrating the equivalence of its ustekinumab biosimilar (AVT04) to the reference product (Stelara) in patients with plaque psoriasis.

As drug companies continue to follow the growing trend adopting more environmentally friendly and socially conscious frameworks, many are choosing to highlight their biosimilar portfolios as an example of their efforts.

In a pharmacokinetic study, Alvotech’s ustekinumab biosimilar referencing Stelara was shown to have comparable safety and efficacy to the reference product, according to the company’s preliminary results.

After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit against 5 companies over the development of Brenzys, an etanercept biosimilar, in Australia.

Biocon’s total revenue for the fourth quarter of the 2022 fiscal year was up 21% from the same period in the prior year, largely due to significant growth in sales for the company’s biosimilar and generic drugs.

Biosimilar manufacturers should consider working together to overcome some of the barriers that prevent biosimilars from entering the market and obtaining market share, according to Ivo Abraham, PhD, chief scientist of Matrix45 and a member of The Center for Biosimilars® Advisory Board.

Amgen’s earnings report for the first quarter of 2022 reveals that as some of its biosimilars experienced increased sales, its sales for reference products that are facing biosimilar competition decreased.

During the Coherus Biosciences earnings call, the company announced that it was terminating its licensing agreement with Innovent Biologics for Byvasda, a bevacizumab biosimilar candidate referencing Avastin.

The United States is about to enter round 2 of biosimilar activity with a pipeline that expands biosimilars into new therapeutic areas, said Sonia Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars, Cardinal Health, during her presentation at Asembia’s Specialty Pharmacy Summit.

Now that the United States’ acceptance of biosimilars matches that in the European Union, developers should be encouraging changes to testing regulations to increase biosimilar accessibility, according to Sarfaraz K. Niazi, PhD, in his recent perspective paper.

Switzerland-based company Fresenius Kabi announced that its pegfilgrastim biosimilar received marketing authorization in Europe and that it has obtained a majority stake in biosimilar manufacturer mAbxience and acquired its subsidiary.

OcyonBio signed a Good Manufacturing Practice (GMP) agreement for the manufacturing of biosimilars in Puerto Rico, while Evio Pharmacy Solutions implemented a strategy aimed at increasing biosimilar affordability.

A phase 1 study testing Celltrion Healthcare’s omalizumab biosimilar in healthy subjects showed similar safety and pharmacokinetic profiles to the reference product (Xolair), as presented at the American Academy of Allergy Asthma and Immunology’s annual meeting.

AbbVie settles outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.

Shanghai Henlius Biotech announced a commercialization agreement with Getz Pharma Limited for an adalimumab biosimilar for various African and Asian countries.

Under a new agreement, Biocon Biologics will take over Viatris’ biosimilar business, according to statements made by the companies.

A report from the National Alliance of Healthcare Purchaser Coalitions detailed the common concerns employers have regarding implementing biosimilars within their health care plans and outlined how they could take charge and make a difference.

Selexis and Generium launched an omalizumab biosimilar on the Russian market; Remsima sales hit a record high for Celltrion Healthcare; Xbrane Biopharma shares long-term results for its ranibizumab biosimilar.

The year 2021 proved to be big for biosimilars, with 4 approvals and increased competition, signaling that FDA is shifting some of their focus from the pandemic back to the growing industry.

Biogen and Xbrane Biopharma signed a commercialization agreement for Xcimzane, a certolizumab pegol biosimilar referencing Cimzia for the treatment of rheumatoid arthritis, psoriasis, and other rheumatologic conditions.

Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country. Current sales of Xolair are estimated at $3.3 billion.

The non-profit organization dedicated to the advancement of biosimilars has appointed Cofounder and President Juliana (Julie) M. Reed, as the new executive director. Reed shared some of her goals for the Biosimilars Forum in an interview with The Center for Biosimilars®.

Two new studies have investigated the adalimumab biosimilar SB5 (Imraldi; Samsung Bioepis) in inflammatory bowel disease (IBD; Crohn’s disease and ulcerative colitis) and non-anterior uveitis associated with Behcet's syndrome (BS).

Many governments have aligned their guidelines with those published by the World Health Organization (WHO) and the European Medicines Agency (EMA).

Wayne Winegarden, PhD, a senior fellow in business and economics at Pacific Research Institute, talks about what kind of educational material still needs to be created and which stakeholders are in need of education on the financial benefits of biosimilars.

In the third quarter, ending December 31, 2021, biosimilars revenues were up 28% year over year for Biocon Biologics Ltd.